A Phase 1, Open-label, Multi-center, Dose-escalation Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of ISU304 in Previously Treated Hemophilia B Patients
Phase of Trial: Phase I/II
Latest Information Update: 18 Dec 2017
At a glance
- Drugs CB 2679d (Primary) ; CB 2679d (Primary) ; Nonacog alfa (Primary)
- Indications Haemophilia B
- Focus Adverse reactions; First in man; Proof of concept
- Sponsors ISU Abxis
- 18 Dec 2017 According to a Catalyst Biosciences media release, the Korean Ministry of Food and Drug Safety (MFDS) has approved a protocol amendment to omit single dose Cohort 4 (300 IU/kg daily "high dose") and move directly to multi-dose Cohort 5 at 150 IU/kg daily in this trial.
- 12 Dec 2017 Interim results presented at the 59th Annual Meeting and Exposition of the American Society of Hematology.
- 09 Dec 2017 Interim results from three cohorts presented in a Catalyst Biosciences media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History